Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety and efficacy of high dose ivig in hospitalized participants with coronavirus disease (covid-19)

Conditions: COVID-19

Summary: the purpose of the study is to determine if high dose intravenous ivig plus smt can reduce the proportion of participants dying or requiring intensive care unit (icu) admission on or before day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on day 29 versus smt alone in hospitalized participants with covid-19.


Eligibility criteria:
inclusion criteria: 1. hospitalized male or female subject ≥ 18 years of age at time of screening who is being treated for covid-19. 2. has laboratory-confirmed novel coronavirus (sars-cov-2) infection as determined by qualitative polymerase chain reaction (pcr) (reverse transcriptase \[rt\]-pcr), or other commercial or public health assay (of any type) in any specimen during the current hospital admission prior to randomization. 3. covid-19 illness (symptoms) of any duration with radiographic infiltrates by imaging (chest x-ray, computed tomography (ct) scan, etc.). 4. pao2/fio2 ratio \> 300 to ≤ 450 mmhg (i.e., arterial oxygen in mmhg divided by fraction inspired oxygen concentration \[e.g., 0.21 for room air\]) 5. any one of the following related to covid-19: i. ferritin \> 400 nanogram per milliliter (ng/ml), ii. lactate dehydrogenase (ldh) \> 300 units per liter u/l, iii. d-dimers \> reference range, or iv. c-reactive protein (crp) \> 40 milligram per liter (mg/l). 6. subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides oral informed consent prior to initiation of any study procedures. exclusion criteria: 1. subject requires invasive mechanical ventilation or icu admission. 2. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator may place the subject at undue medical risk. 3. the subject has had a known (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin. 4. subject has known (documented) hereditary fructose intolerance (hfi). 5. a medical condition in which the infusion of additional fluid is contraindicated. 6. shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the principal investigator not able to be reversed. 7. subject with known (documented) thrombotic complications to polyclonal ivig therapy in the past. 8. subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event. 9. subject with limitations of therapeutic effort (eg, 'do not resuscitate' status). 10. female subject who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline. 11. subject participating in another interventional clinical trial with investigational medical product or device.

Keywords: coronavirus disease severe acute respiratory syndrome coronavirus 2 sars-cov-2
environmental factors on dfus incidence - a mixed-mode survey

Conditions: Diabetic Foot; Diabetic Foot Ulcer

Summary: diabetic foot ulcers (dfus) pose a significant threat to the health and wellbeing of diabetic patients. affecting around 1 in 10 people (nhs north west coast strategic clinical networks, 2017) regardless of a diabetes type they often result in a drastically worsened quality of life and can lead to severe consequences including leg amputations. this survey will help to understand what role various environmental factors have on the incidence, severity and recurrence of dfus. results from this study will help healthcare professionals as well as patients to better understand various factors involved in dfu prevalence. moreover, this survey could help to appreciate whether a more holistic approach should be followed when assessing dfu risk and deciding on therapy. this study will be run across five sites in england between october 2023 and may 2024 and will involve a small pilot study (informal interview) and an anonymous, ten-minute questionnaire. any adult with an ongoing or past dfu will be eligible. participants will be asked about their job type, quality of life, diabetic therapy, comorbidities, and environmental factors questions. there will be an option for a follow-up questionnaire after 12 weeks to understand the healing process and changes to the quality of life following a dfu incident. additionally, patients may consent to provide access to excerpts from their anonymized medical history details (prescribed medications) to better understand their diabetic and dfu history. this study will be run as part of an industrial, london interdisciplinary biosciences consortium (lido) phd project investigating the autologous platelet-rich plasma gel for diabetic foot ulcers (rapid™ biodynamic haematogel) with king's college london as funded by the biotechnology and biological sciences research council (bbscr) and biotherapy services ltd.


Eligibility criteria:
inclusion criteria: 1. adult (\>18 years old) 2. diagnosed with diabetes 3. currently having or have had at least one diabetic foot ulcer incident in the past 4. resident in england 5. able to consent exclusion criteria: 1. underaged 2. not diagnosed with diabetes 3. never had a dfu incident 4. unable/refusing to consent 5. a non-english resident

Keywords: diabetic foot ulcer diabetes environmental factors
role of stress cardiac mri in predicting adverse clinical events in patients with known or suspected ischemic heart disease

Conditions: Coronary Artery Disease

Summary: the investigators plan to use retrospective data to assess heart function and structure abnormalities through the use of an approved vasodilating agent for stress cardiac mri tests. the investigators are interested in how these mri findings relate to long-term prognosis in people who are at risk for cardiac disease.


Eligibility criteria:
inclusion criteria: * age \>/= 21 years old * no contraindications for cardiac mri (by renal function or metallic hazards)
a study of tamiflu (oseltamivir) treatment in laboratory-confirmed influenza.

Conditions: Influenza

Summary: this study will evaluate the efficacy and safety of tamiflu in patients with clinically-diagnosed influenza occurring during an influenza outbreak within the community. patients will be randomized to receive tamiflu 75mg bid orally plus support therapy (nsaids and antibiotics) or support therapy alone. the anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-64 years of age; * ambulatory; * influenza-like illness; * positive rapid assay for detection of influenza antigen. exclusion criteria: * presentation \>36h after onset of symptoms; * influenza-like symptoms outside an outbreak based on local surveillance activities; * influenza vaccination between november 2006 and january 2007; * receipt of antiviral therapy, systemic steroids or immunosuppressants within 2 weeks prior to study day 1.
volumetric laser endomicroscopy's (vle) diagnostic accuracy validation study: impact on clinical management study

Conditions: Biliary Stricture; Pancreas Cancer; Cholangiocarcinoma; Bile Duct Cancer; Bile Duct Neoplasms Malignant; Bile Duct Neoplasms; Bile Duct Lesions; Bile Duct Obstruction; Bile Duct Diseases; Bile Duct Obstruction, Extrahepatic; Bile Duct Stenosi; Bile Duct Adenoma; Pancreatic Duct Stricture; Pancreatic Duct Stenosis; Pancreatic Duct Obstruction; Pancreatic Ductal Adenocarcinoma; Primary Sclerosing Cholangitis

Summary: the purpose of this study is to assess the interobserver agreement (iov) for pancreatico-biliary volumetric laser endomicroscopy (vle) de-identified clips using the new vle criteria. this is an interobserver study to validate vle criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.

objective: validate diagnostic impact of vle diagnostic accuracy on clinical management primary objectives: 1. interobserver study for criteria validation and accuracy, positive predictive value (ppv) and negative predictive value (npv), sensitivity and specificity. 2. evaluation of vle diagnostics on clinical management (increased accuracy/faster detection) 3. determination of learning curve to standardize credentialing for endoscopists to use and interpret vle imaging for biliary/pancreatic treatment management. b. hypotheses / research question(s) the new vle criteria for biliary and pancreatic duct strictures increase accuracy, thus leading to substantial impact on clinical management (screening and treatment) study design (2 phase): * phase 1: primary objective 1 and 2 part of the study will be completed. * phase 2: primary objective 3 of the study will be conducted within 1 month. study timeline: 3 months post wirb approval. sample size: 40 vle clips of at least 20 seconds featuring one or more the vle criteria. all clips will have confirmed diagnosis for accuracy analysis. all clips will be de-identified. all clips will be removed from redcap and other secure cloud storage upon completion of study. clips will be supplied by ninepoint medical, the company behind vle oct. all vle clips will be from a dataset of clips collected from adults \> 18 and who underwent endoscopic retrograde cholangiopancreatography (ercp) with indeterminate biliary stricture indications. the clips are chosen based on the quality of the clips, duration, final diagnosis and presence of either benign or malignant criteria. investigators: up to 30 expert and non-expert endoscopists currently using vle

Eligibility criteria:
inclusion criteria: vle clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology - exclusion criteria: -

Keywords: bile duct stricture bile duct neoplasm bile duct obstruction bile duct lesion cholangiocarcinoma pancreatic duct stricture pancreatic duct obstruction pancreatic cancer primary sclerosing cholangitis
the learning effects of task-priority strategy on dual-task weight shifting and brain plasticity in patients with parkinson's disease

Conditions: Postural and Suprapostural Performance During Dual Tasking in Patients With Parkinson's Disease

Summary: (1) postural and suprapostural performance of a dual task would be differently affected by the strategy of task prioritization and (2) the cortical activation is different according to attentional focus strategies.

these hypothesis would be tested by gait performance, suprapostural accuracy and relative power spectrum of eeg.

Eligibility criteria:
inclusion criteria: * 1. modified h-y stage ii-iii parkinson's disease 2. no other diseases 3. non-demented pd 4. non-tremor pd exclusion criteria: * none

Keywords: parkinson dual-task training attention electroencephalogram (eeg)
open lung maneuvers during high frequency oscillatory ventilation in preterm infants

Conditions: High Frequency Oscillation Ventilation; Extreme Prematurity; Lung Injury, Acute

Summary: to assess whether stepwise oxygenation-guided lung recruitment at regular intervals reduces the oxygen saturation index (osi = mean airway pressure × fraction of inspired oxygen × 100 / peripheral oxygen saturation, osi = mapxfio2x100/spo2) averaged over high frequency oscillation ventilation (hfov) time in extremely preterm infants.

background: open lung maneuvers aim to recruit and stabilize the majority of collapsed alveoli, using oxygenation as an indirect variable for lung volume. the stepwise oxygenation-guided lung recruitment procedure during frequency oscillatory ventilation (hfov) in preterm infants has a low risk of lung hyperinflation and air leak syndrome. nevertheless, open lung maneuvers at regular intervals during hfov to maintain or restore oxygenation is not implemented as a routine procedure in the neonatal intensive care. aim of the study: to assess whether stepwise oxygenation-guided lung recruitment at regular intervals reduces the oxygen saturation index (osi = mean airway pressure × fraction of inspired oxygen × 100 / peripheral oxygen saturation, osi = mapxfio2x100/spo2) averaged over hfov time in extremely preterm infants. study design: single center randomized controlled study. methods: thirty-six extremely preterm infants below 28 weeks of gestational age and on high frequency oscillation ventilation receive either stepwise oxygenation-guided lung recruitment maneuver at regular intervals (intervention) and upon decision of the care giving team (intervention group) or lung recruitment maneuver only upon decision of the care giving team (standard, control group). the primary outcome is the oxygen saturation index averaged over hfo ventilation time. the observation time of the hfov will be limited to at most seven days. sample size: fifteen infants need to be enrolled in each group to have 80% power (at a two-sided alpha level of 5%) to detect a difference of 25% in the oxygen saturation index between the intervention group and the control group. main outcome variables: oxygen saturation index averaged over hfo ventilation time. secondary outcome variables: bronchopulmonary dysplasia (bpd); days of ventilation; oxygen saturation index averaged over ventilation time (hfo and conventional ventilation); the following variables measured before, during and after a single stepwise oxygenation-guided recruitment maneuver: echocardiographic parameters, reactance, relative impedance changes, lung ultrasound measurements, transcutaneous partial carbon dioxide (co2), blood pressure, heart rate.

Eligibility criteria:
inclusion criteria: preterm infants * born below 28 weeks of gestational age * not older than 29 weeks of postmenstrual age * receive hfov exclusion criteria: * known congenital anomalies of the heart, of the lung, and/or of the central nervous system * known chromosomal abnormalities * participation in other intervention trials
skeletal and cognitive effects of nutrition from eggs

Conditions: Bone Health; Cognitive Health

Summary: this project is the first egg feeding randomized controlled trial (rct) in children. the goal of this rct is to determine if eating formulated whole egg products for 9 months improves bone health and cognitive function in children ages 9-13 years more than children consuming products made of milk powder or gelatin.

this 9-month randomized controlled trial is an egg product intervention in otherwise healthy, 9-13 year-old children in the early stages of puberty (n=120). it will assess changes in bone material and geometric properties using dual energy x-ray absorptiometry (dxa) and peripheral quantitative computed tomography (pqct). cognitive function will be measured by the national institute of health's toolbox. participants will be randomized to one of 3 treatment (i.e., whole egg powder, whole milk powder, or gelatin) groups, and instructed to consume the food projects 10 times/week in substitute for other similar food products in their diet for 9-months. five product choices per treatment group will be provided. the food products were developed specifically for this study by the university of georgia's food product innovation and commercialization center and consumer tested. additionally, these food products will be micro-tested prior to distribution to participants. we hypothesize that children consuming whole egg products will have enhanced bone outcomes and cognitive abilities in comparison to those consuming whole milk powder or gelatin.

Eligibility criteria:
inclusion criteria: * apparently healthy and well-nourished * white, black or hispanic * males and females between the chronological ages of 9-13 years * sexual maturation rating, as measured by tanner, at stages 2/3. * must be willing to provide a blood sample * not allergic to egg or egg products, milk or milk products, or gelatin exclusion criteria: * achievement of menarche (females) * sexual maturation rating, as measured by tanner, at stages 4/5 * known bone disease or disease know to influence bone metabolism (e.g., cerebral palsy, intestinal malabsorption, juvenile rheumatoid arthritis) * known growth disorders * the use of medications that may influence bone metabolism (e.g., corticosteroids, attention-deficit/hyperactivity disorder medications) * allergic to egg or egg products, milk or milk products, or gelatin

Keywords: bone cognition egg protein
bernese next of kin survey following organ donation request

Conditions: Organ Donation; Next of Kin; Post Traumatic Stress Disorder

Summary: 6 to 18 months after organ donation request a next of kin survey using a standardized questionnaire was conducted.


Eligibility criteria:
inclusion criteria: next of kin involved in request for organ donation
induction-maintenance of lopinavir/r in hiv-infected subjects

Conditions: HIV Infections

Summary: this study will assess the safety, tolerability and antiviral activity of a simplified pi-based treatment regimen (kaletra,ä) compared to conventional haart regimens in patients infected with hiv-1 who are on their first boosted-pi antiretroviral treatment regimen. the potency of the antiviral activity of kaletra has been clearly demonstrated in a wide spectrum of patients in a number of different clinical trials.6-9 the durable viral suppression seen after 4 years of therapy10 proves that it can provide effective, long-term treatment for people with hiv-1. data from one of these trials (m97-720),6 an ongoing phase ii study of lopinavir/ritonavir in combination with nrtis suggests there may be a role for monoclass therapy with kaletra in the treatment of hiv-1-infection.


Eligibility criteria:
inclusion criteria: * subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the trial that are relevant to his or her decision to take part, by signing and dating the irb / iec approved informed consent form. * subject is hiv positive and on their first antiretroviral treatment regimen, based on any two nrtis plus lopinavir/ritonavir or a ritonavir-boosted pi combination. subject must have had no previous exposure to other regimens. * subject has a viral load \<50 copies/ml at the time of baseline evaluation for at least 6 months. * subject has a cd4 cell count ³ 100 cells/mm3. * subject is aged \>18 years. * vital signs, physical examination and laboratory results do not exhibit evidence of acute illness. * subject has not been treated for an active opportunistic infection within 30 days of screening. * if female, subject has a negative pregnancy test and agrees to use, for the duration of the study, a barrier method of birth control that has a history of proven reliability as judged by the investigator. * subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with any of the antiretroviral drugs in their treatment regimen. the subject agrees not to take any medication, including over-the-counter medicine, alcohol, or recreational drugs without the knowledge and permission of the principal investigator exclusion criteria: * subject has current uncontrolled substance abuse or psychiatric illness that could preclude compliance with the protocol. * subject has a viral load of \> 50 copies/ml * subject is hbsag + * subject has active tuberculosis or an opportunistic infection. * subject has active malignancy (except kaposi's sarcoma). * subject has liver failure as evidenced by alt / ast \> 5 x upper limit of normal (uln). * female subject is pregnant or lactating. * subject has received an investigational drug within 30 days prior to the initiation of the study. * subject has modified his/her antiretroviral therapy during the 3 months prior to baseline or is intending to do so during the course of the study.

Keywords: hiv simplification monotherapy treatment naive hiv-1 infection
a comparison of the effectiveness of massage and kinesio taping in neck pain

Conditions: Neck Pain

Summary: this study aimed to compare the effectiveness of massage and kinesio taping on pain, range of motion, disability and quality of life in patients with chronic neck pain.

neck pain is a common condition, affecting 30% to 50% of the general population, and is most prevalent in middle age.33 it is usually accompanied by a substantial effect on daily life, resulting in an extensive use of health care resources. several physical therapy applications such as massage therapy, kinesio taping, thermal and electrophysiological agents, hydrotherapy/spa therapy, and therapeutic exercises especially neck stabilization exercise are used to manage fm. both massage therapy and kinesio taping have a favorable effect on clinical symptoms. however, it is not clear which method is more effective. therefore, this study aimed to compare the effectiveness of massage and kinesio taping on pain, range of motion, disability and quality of life in patients with chronic neck pain.

Eligibility criteria:
inclusion criteria: * 18 to 65 years of age, * having generalized neck pain for more than 3 months, * being volunteer exclusion criteria: * pregnancy, * inflammatory rheumatologic diseases, * malignity, * structural deformity, * previous surgery related to the cervical spine, * cervical spinal stenosis, * being allergic to kinesio tape * severe psychological disorder, * any intervention that included exercise or physical therapy in the last 3 months.

Keywords: neck pain, massage, kinesio tape,
evaluation of the effectiveness and safety of abastroke

Conditions: Stroke

Summary: the aim of the project is to confirm the effectiveness and safety of the abastroke technology, which uses the principles of applied behavior analysis (aba) in the rehabilitation of cognitive deficits in patients after strokes. the study is comparative in nature, where a group of 100 patients will be included in this randomized study, divided equally into a study group and a control group. the purpose of the study is also to demonstrate that this non-invasive new rehabilitation technology based on the abastroke computer software supports the process of rehabilitation in the field of cognitive functions together with standard pharmacological therapy, including the possibility of using rehabilitation (as recommended by researchers and other doctors conducting rehabilitation of a patient after a stroke brain). abastroke can lead to improved cognitive functions (such as abstraction, short-term memory, visuospatial functions, executive functions, language, verbal fluency, allopsychic orientation, and attention) and is delivered via a mobile device app that can be used at home.


Eligibility criteria:
inclusion criteria: 1. men and/or women between the ages of 18 and 70 2. condition after an ischemic or hemorrhagic stroke that occurred within the last 6 months before the start of the study. 3. moca score \>14 and \<26 points. 4. signing of the informed consent form by each study participant. exclusion criteria: 1. vision disorders of various etiologies, which, in the opinion of the researcher, prevent the efficient use of a device using electronic displays. 2. psychotic episodes and/or manic episodes and/or severe depression (beck score 26 or higher) in the past year. 3. history of alcohol abuse or physical dependence on opioids in the past 2 years. 4. unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social circumstances) that could affect the patient's ability to attend scheduled appointments and use the investigational technology as determined by the investigator. 5. moca score \ 25 points. 6. treatment of procognitive drug therapy in the last 6 months before inclusion in the study: nootropics (pro-cognitive): cerebrolysin, citicoline, vinpocetine, nicergoline, piracetam, gingo biloba preparations, lecithin, cholinesterase inhibitors: donepezil, rivastigmine, galantamine, nmda receptor antagonist: memantine.